Kornimate/medical-research-clean huggingface dataset:
effect of virtual reality and serious games on pain, fear, anxiety, and satisfaction during skin prick testing in children

Conditions: Pain; Anxiety; Fear; Allergy

Summary: this randomized controlled trial evaluated the effectiveness of virtual reality (vr) and serious gaming (sg) in reducing pain, fear, and anxiety, and improving satisfaction during skin prick testing (spt) in children aged 6-12 years. a total of 90 children were randomly assigned to three groups: standard care (control), vr, or sg. the vr group watched a 360° animated video using a headset, while the sg group played subway surfers on a tablet. pain (wbfps), fear (cfs), anxiety (cas-s), and satisfaction (vas) were measured post-procedure.


Eligibility criteria:
inclusion criteria: * children aged 6 to 12 years * scheduled to undergo an allergy skin prick test * no visual impairments * no use of anxiolytic or analgesic medication within the past six hours * voluntary agreement to participate (child assent and parental consent) exclusion criteria: * not within the 6-12 age range * not scheduled for an allergy skin prick test * presence of visual impairments * use of anxiolytic or analgesic medication within the past six hours * refusal to participate
feasabilty and physiological effects of a ventilation strategy combining peep and tidal volume titration according to inspiratory and expiratory transpulmonary pressures in ards patients.

Conditions: ARDS, Human

Summary: expiratory or inspiratory transpulmonary pressures have been proposed to optimize ventilator settings in patients with ards. the aim of this study is to assess the feasibility and the physiological effects of a new method based on both expiratory and inspiratory transpulmonary pressures.

expiratory or inspiratory transpulmonary pressures have been proposed to optimize ventilator settings in patients with ards. a positive expiratory transpulmonary pressure may be considered as a target to limt the risk of collapse in dependant lung regions. some authors propose to titrate peep to target an inspiratory transpulmonary pressure of 20cmh20 to limit the risk of overdistension in non-dependant regions.the aim of this study is to assess the feasibility and the physiological effects of a new method based on both expiratory and inspiratory transpulmonary pressures.

Eligibility criteria:
inclusion criteria: * age 18 years or older * moderate to severe ards * written informed consent obtained from patient' surrogates exclusion criteria: * pneumothorax * known pregnancy * contraindication to electrical impedance tomography or esophageal pressure measurements
sleep-disordered breathing in heart failure - the schlahf-registry

Conditions: Congestive Heart Failure; Left Ventricular Systolic Dysfunction

Summary: objective target of the registry is to investigate the prevalence of sdb as well as the clinical characteristics of patients with and without sdb as well as the predominant type of sdb. for this purpose data from patients suffering from chronic, symptomatic heart failure with impaired left ventricular ejection fraction will be collected prospectively.

despite recent advances in pharmacological treatment, congestive heart failure (chf) continues to cause debilitating symptoms, frequent hospital admissions and a high mortality. despite of therapy with beta-blockers and ace-inhibitors many patients have persistent symptoms and most will eventually die of cardiovascular causes, often from progressive heart failure. sleep disordered breathing (sdb) is known to cause consequences, which have negative effects on heart failure. objective target of the registry is to investigate the prevalence of sdb, clinical characteristics, symptoms and the degree and type of sdb in patients with chronic hf. for this purpose data from patients with chronic heart failure will be collected prospectively.in the registry several cardiologists in private practice or hospital and cooperating sleep laboratories shall participate. cardiologists screen patients with chronic heart failure (chronic hf) prospectively. in case of suffering from chronic hf for at least 12 weeks since diagnosis, with nyha iii-iv or nyha class ii with at least one hospitalisation for hf in the last 12 months. written informed consent for data privacy aspects must be obtained before screening for sdb. patients who satisfy to all inclusion- and exclusion criteria will be included consecutively into the registry.

Eligibility criteria:
inclusion criteria: * patients must be over 18 * chronic heart failure (at least 12 weeks since diagnosis) according to the current applicable guidelines * left ventricular systolic dysfunction (lvef ≤ 45% by imaging method such as echocardiography, radionuclide angiography, left ventriculography, or cardiac magnetic resonance imaging) documented less than 12 weeks * nyha class iii or iv at the time of inclusion or nyha class ii with at least one hospitalisation for hf in the last 24 months * patient is able to fully understand study information and signed informed consent exclusion criteria: * life expectancy \< 1 year for diseases unrelated to chronic hf * cardiac surgery, percutaneous coronary intervention (pci), myocardial infarction (mi) or unstable angina within 6 months * crt-implantation (either crt-d or crt-p) scheduled or within 6 months * transient ischemic attack (tia) or stroke within 3 months * hemodynamically significant uncorrected primary valvular heart disease, obstructive or regurgitant, or any valvular disease expected to lead to surgery * acute myocarditis/pericarditis within 6 months * current cpap or bilevel therapy

Keywords: chronic heart failure heart failure hf sleep-disordered breathing sdb nyha lvef cheyne stokes central sleep apnoea sleep apnoea
influence of emotion in a test run forgetfulness

Conditions: Schizophrenia; Healthy Volunteer

Summary: currently there is uncertainty on how schizophrenic patients feel pain. pain has several components including cognitive behavior which allow humans to perceive it as a negative emotion. it is difficult to say precisely what are the differences in cognitive processing between the emotional component of pain and painless another negative emotion (eg fear). however, pain and negative emotion have some neural networks together and there are many common ways between emotional processing (pain or negative) and storing information (limbic system).

the study is to go 1 time in hospital for memory test. these tests consist in: * group 1: words to painful sense will be shown on a screen, one at a time for 5 seconds. patient or healthy volunteer will need to retain them. then these same words, mixed with others that patient/healthy volunteer will not learn, will again be displayed on the computer screen one at a time for 5 seconds. upon the occurrence of a word, patient/healthy volunteer must press the 'l' key if they think they have learned the word or the "d" key on the keyboard if they feel that they have not learned this word. * group 2: words to negative sense will be shown on a screen, one at a time for 5 seconds. patient or healthy volunteer need to retain them. then these same words, mixed with others that patient/healthy volunteer will not learn, will again be displayed on the computer screen one at a time for 5 seconds. upon the occurrence of a word, patient/healthy volunteer must press the 'l' key if they think they have learned the word or the "d" key on the keyboard if they feel that they have not learned this word. 15 schizophrenic will be included in group 1 and 15 other schizophrenics in group 2. 15 healthy volunteer will be included in group 1 and 15 other healthy volunteer in group 2.

Eligibility criteria:
inclusion criteria: * patients: * schizophrenic age 18 years to 55 years * stabilized, clinical and therapeutic point of view, since at least one month. * good knowledge of french * healthy volunteer * age 18 years to 55 years * good knowledge of french * matching on age (± 5 years) and level of study patients exclusion criteria: * patients * history of head trauma, neurological disease with cerebral repercussion or not stabilized or serious physical illness causing pain\> 3 months. * recent amendment of psychotropic therapy (\<1 month) * consumption of benzodiazepines long-term (negative effect on memory capacity) * troubles related to the use of a psychoactive substance, as defined by the dsm iv (recent use, abuse, dependence or withdrawal). * healthy volunteer * consumption of benzodiazepines long-term (negative effect on memory capacity) * troubles related to the use of a psychoactive substance, as defined by the dsm iv (recent use, abuse, dependence or withdrawal).

Keywords: schizophrenia memory pain
study of tisagenlecleucel in combination with pembrolizumab in r/r diffuse large b-cell lymphoma patients

Conditions: Diffuse Large B-cell Lymphoma

Summary: a multi-center, open-label, phase ib study to evaluate the safety and efficacy of the administration of tisagenlecleucel in combination with pembrolizumab in patients with r/r dlbcl who have received 2 or more lines of systemic therapy, including an anti-cd20 and anthracycline based chemotherapy and having failed to or are not candidates for asct. the study will consist of 2 parts: dose timing selection part and expansion part.


Eligibility criteria:
inclusion criteria: * confirmed dlbcl per local histopathology assessment. * relapsed or refractory disease after having recieved 2 or more lines of systemic therapy, including anti-cd20 and anthracycline based chemotherapy, and either having progressed after (or relapsed after) asct, or being not candidates for or not consenting to asct. * measurable disease at time of enrollment * ecog performance status that is either 0 or 1 at screening. exclusion criteria: * patients with richter's transformation, and burkitt lymphoma, and primary dlbcl of cns. * prior treatment with any prior anti-cd19/anti-cd3 therapy, or any other anti-cd19 therapy. * patients with active cns involvement are excluded, except if the cns involvement has been effectively treated and provided that local treatment was \>4 weeks before enrollment. * prior allogeneic hsct. * unstable angina and/or myocardial infarction and/or coronary artery bypass graft (cabg), or stroke within 6 months prior to screening, and/or impaired cardiac function or clinically significant cardiac disease * patients with a history of prior treatment with anti-pd-1, anti-pd-l1, anti-pd-l2, anti-ctla-4 antibodies, other immune checkpoint inhibitors. * history of interstitial lung disease or (non-infectious) pneumonitis that required oral or intravenous steroids (other than copd exacerbation) or current pneumonitis. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: lymphoma tisagenlecleucel diffuse large b-cell lymphoma ctl019 portia dlbcl tisagenlecleucel pembrolizumab r/r diffuse large b-cell lymphoma relapsed/refractory diffuse large b-cell lymphoma
brain uptake and safety with probable alzheimer's disease, amnestic mild cognitive impairment and healthy volunteers

Conditions: Alzheimer's Disease; Amnestic Mild Cognitive Impairment

Summary: study to assess brain uptake and safety of ah110690 (18f) injection in subjects with probable alzheimer's disease, amnestic mild cognitive impairment and healthy volunteers.


Eligibility criteria:
inclusion criteria: * the subject meets national institute of neurological and communicative disorders and stroke; alzheimer's disease and related disorders association (nincds-adrda) criteria for clinically probable ad and diagnostic and statistical manual of mental disorders, 4th edition (dsm-iv) criteria for dementia of alzheimer's type. * the subject meets petersen criteria for amnestic mci. * the subject has no evidence of cognitive impairment by medical history. exclusion criteria: * the subject may not be able to complete the study as judged by the investigator. * the subject has received ionising radiation exposure from clinical trials in the last 12 months or has participated in any other clinical study within 30 days of study entry. * the subject has known allergies to \[18f\]ah110690 or \[11c\]pib or their constituents. * the subject is pregnant or breast-feeding. * the subject has a history of alcohol and/or drug abuse within the last 2 years based upon a review of medical records. * the subject has a contraindication for mri (including, but not limited to, claustrophobia, pacemaker, presence of metallic fragments near the eyes or spinal cord, or cochlear implant). * the subject has a history of head injury with loss of consciousness.

Keywords: alzheimer's disease
japanese cto pci expert registry

Conditions: Chronic Total Occlusion of Coronary Artery

Summary: the purpose of this study is to establish a consensus of treatment strategy of percutaneous coronary intervention (pci) for chronic total occlusion (cto) through patient registry of pci for cto performed by japanese certified operators.


Eligibility criteria:
inclusion criteria: patients eligible for pci patients who underwent pci for cto lesions that contain the following: 1. thrombolysis in myocardial infarction trial (timi) 0 2. the occlusive period more than 3 months or unknown 3. the main coronary arteries (segment 1-3, 5-8, 11, 13), branches that have large perfusion area (segment 4pl, 9/10, 12) and graft exclusion criteria: patients ineligible for pci judged in clinical practice
changes in resting metabolic rate following orthopedic surgery

Conditions: Metabolism; Disorder, Postprocedural; Resting Metabolic Rate; Post Operative Nutrition

Summary: this project is intended to determine the magnitude and duration of rmr changes in patients receiving orthopedic surgery. the result will help to guide postoperative nutrition recommendations in patients receiving orthopedic surgery.

surgery produces a catabolic response in the body that shifts metabolism from glucose to fat and protein. despite no studies examining aclr, studies of other orthopedic surgeries demonstrate increased postoperative energy expenditure, as well as a shift to beta-oxidation. additionally, in most patients, these changes reverted to baseline within six weeks, although a subset of patients did not return to baseline until beyond 12 weeks. this project will improve our understanding of magnitude and duration of rmr changes following orthopedic surgery, and the subsequent perioperative dietary suggestions that should be made to improve patient outcomes. currently, postoperative dietary suggestions are not surgery nor patient specific. determining how orthopedic surgery effects rmr will help to personalize perioperative treatment, rehabilitation, and recovery. better understanding the change in rmr following orthopedic surgery and implementing more accurate dietary modifications will help to ensure positive outcomes and control of infection following orthopedic surgery.

Eligibility criteria:
inclusion criteria: * any individual over 15 undergoing an orthopedic surgery. exclusion criteria: * pregnant female * \< 15 years old
a study to compare two techniques for pain control after bariatric surgery

Conditions: Pain, Postoperative; Bariatric Surgery Candidate

Summary: the purpose of this study is to compare the postoperative pain and other clinical outcomes in patients who, during bariatric surgery, will be injected with a local anesthetic (ropivacaine) through two different techniques.


Eligibility criteria:
inclusion criteria: * patients undergoing elective bariatric surgery * age ≥ 18 years * signed informed consent exclusion criteria: * pregnant or lactating women, * known allergy to local anesthetics * chronic pain syndrome.

Keywords: transversus abdominis plane (tap) block local anesthetic infiltrations
effect of glossopharyngeal versus diaphragmatic breathing exercise on pulmonary function after decortication surgery

Conditions: Pulmonary Disease

Summary: this study will be conducted to compare between the effect of glossopharyngeal and diaphragmatic breathing exercises on pulmonary functions after decortication surgery

lung decortication is a well-known procedure for the treatment of empyema. persistent lung collapse and non-expansion of the lung parenchyma are frequently noticed in the postoperative period after decortications, chest physiotherapy plays a crucial role in the re-expansion of underlying parenchyma. there is an increased flow of patients after decortication surgery to hospitals who suffer from decreased lung volumes so the hospitalization period for them increases which puts an economical burden on health insurance services with a decreased level of quality of life that is the most concern to improve patient status and relieve this burden. so this study aims to improve patient's lung volumes and arterial blood gas parameters which improves patient status through two various forms of breathing exercises.

Eligibility criteria:
inclusion criteria: * the participant's body mass index (bmi) will be ranged from 25- 29.9 kg/m2 * the patient will receive treatment after 24 hours after decortication * the study will be in the intensive care unit (icu). * the patients have unilateral lung decortication * their vital capacity is 70% or less. exclusion criteria: * cancerous patient. * inability to comprehend and follow instructions as in dementia * paralytic involvement of thorax muscle * abdominal diseases that affect diaphragmatic function * diaphragmatic paralysis
memantine for agitation in dementia

Conditions: DEMENTIA

Summary: we plan to evaluate the use of memantine in alzheimer's disease to control agitation in the acute situation i.e under 12 weeks

agitation is a cause of morbidity and mortality in alzheimer's due to distress and use of medication with side effects. memantine has beed shown to be associated with less agitation and a recent study by forrest pharmaceuticals failed to recruit. we will perform a 12 week rct in 164 patients to test this hypothesis in a locality with no competing studies and in a clinical setting where the drug is not often used. we will compare with placebo and also use a rescue protocol derived from international best practice.

Eligibility criteria:
inclusion criteria: 1. residential/inpatients at recruitment to the study with a history of at least 2 weeks behavioural disturbance. 2. alzheimer's disease only as per mckhann criteria + hachinski score\<=4. 3. moderately severe to severe alzheimer's disease (baseline mmse \</=19). 4. clinically significant agitation that requires treatment. 5. severity of agitation defined by cohen mansfield agitation inventory (cmai) \> /=45. 6. age \>/= 55. exclusion criteria: 1. memantine usage in the 4 weeks prior to the start of the study. 2. on cholinesterase inhibitor for less than 3 months and not on a stable dose. 3. anti-psychotic, anti-epileptic, antidepressant, benzodiazepine, lithium or hypnotic dosage alteration in the 2 weeks prior to the start of the study. 4. antiparkinsonian medication. 5. hypersensitivity to memantine or any of the excipients in the formulation. 6. severe renal impairment. 7. epilepsy, history of convulsions or seizure, or receiving any anti-epileptic treatment. 8. concomitant usage of n-methyl-d-aspartate (nmda) antagonists such as amantadine, ketamine or dextromethorphan. 9. recent myocardial infarction, uncompensated congestive heart failure and uncontrolled hypertension. 10. severe, unstable or poorly controlled medical illness. 11. any disability that may interfere with the patient completing the study procedure. 12. active malignancy. 13. delirium, pain or any medical illness as a clear cause of agitation. 14. any important drug interactions: prohibited during study and in the 14 days preceding enrollment/inclusion are: analgesic dextromethorphan, dopaminergics- amantadine, warfarin due to theoretical inr prolongation.

Keywords: agitation dementia alzheimer's
vinorelbine in treating patients with metastatic prostate cancer

Conditions: Prostate Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of vinorelbine in treating patients with metastatic prostate cancer that has not responded to hormone therapy.

objectives: i. evaluate the efficacy of vinorelbine in patients with metastatic hormone-resistant prostate cancer. ii. evaluate the toxicity of vinorelbine in these patients. iii. evaluate the quality of life of these patients, and correlate quality of life with psa response. outline: patients receive a 5-10 minute intravenous infusion of vinorelbine on day 1 and day 8 of a 21-day course. patients with stabilization of their disease, partial response, or complete response, receive a maximum of 12 courses of treatment. patients showing disease progression or severe toxic side effects discontinue treatment. quality of life and pain are assessed prior to treatment, at days 1 and 8 of each course, and at end of the treatment. patients are followed every 3 months until disease progression. projected accrual: a total of 14-40 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: histologically or cytologically proven metastatic stage iv prostate cancer proven hormonal resistance measurable or evaluable disease psa at least 3 times upper limit of normal no leptomeningeal or brain metastases patient characteristics: age: 18 to 85 performance status: who 0-2 life expectancy: greater than 12 weeks hematopoietic: wbc at least 3500/mm3 or granulocyte count at least 2000/mm3 hemoglobin at least 9 g/dl platelet count at least 100,000/mm3 hepatic: bilirubin no greater than 1.5 times upper limit of normal (uln) sgot no greater than 2.5 times uln renal: creatinine no greater than 1.5 times uln other: no acute severe infections no other neoplastic diseases except curatively treated basal cell or squamous cell carcinoma of the skin, or relapse free for more than 5 years after curative treatment of a neoplasm prior concurrent therapy: biologic therapy: not specified chemotherapy: no prior cytostatic chemotherapy endocrine therapy: at least 1 month since antiandrogens prior hormonal therapy required radiotherapy: no radiotherapy within the past 4 weeks no radiotherapy to the lesions used to evaluate activity of the study drug surgery: prior orchiectomy allowed other: no other investigational drugs during the last month no prior therapy with cytostatic agents

Keywords: stage iv prostate cancer